VABOMERE
These highlights do not include all the information needed to use VABOMERE safely and effectively. See full prescribing information for VABOMERE. VABOMERE (meropenem and vaborbactam) for injection, for intravenous use Initial U.S. Approval: 2017
Approved
Approval ID
e237fd0f-3050-42a3-b43e-b6fb4824e93d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 19, 2023
Manufacturers
FDA
Melinta Therapeutics, LLC
DUNS: 079949853
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Meropenem-Vaborbactam
PRODUCT DETAILS
NDC Product Code70842-120
Application NumberNDA209776
Marketing CategoryC73594
Route of AdministrationINTRAVENOUS
Effective DateSeptember 30, 2023
Generic NameMeropenem-Vaborbactam
INGREDIENTS (3)
VABORBACTAMActive
Quantity: 1 g in 2 g
Code: 1C75676F8V
Classification: ACTIB
MEROPENEMActive
Quantity: 1 g in 2 g
Code: FV9J3JU8B1
Classification: ACTIB
SODIUM CARBONATEInactive
Quantity: 575 mg in 2 g
Code: 45P3261C7T
Classification: IACT